Clinical Trial: NCT06968585
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
Official Title
A Phase III,Multicenter,Randomized,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Conditions
HER2-positive Breast Cancer
Intervention / Treatment
- Drug: A166
- Drug: T-DM1
Other Study ID Numbers
- KL166-III-06
Start Date (Actual)
2023-07-18
Primary Completion Date (Estimated)
2026-11-30
Study Completion Date (Estimated)
2028-03-31
Enrollment (Actual)
365
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
Official Title
A Phase III,Multicenter,Randomized,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Conditions
HER2-positive Breast Cancer
Intervention / Treatment
- Drug: A166
- Drug: T-DM1
Other Study ID Numbers
- KL166-III-06
Start Date (Actual)
2023-07-18
Primary Completion Date (Estimated)
2026-11-30
Study Completion Date (Estimated)
2028-03-31
Enrollment (Actual)
365
Study Type
Interventional
Phase
Phase 3